. /.   WORLD TRADE  
ORGANIZATION  G/SPS/N/USA/1966 
21 December 2009  
 (09-6657) 
Committee on Sanitary a nd Phytosanitary Measures Original:   English 
  
 
NOTIFICATION 
 
1. Notifying Member:  UNITED STATES
 
If applicable, name of local government involved:    
2. Agency responsible:  US Food and Drug Administration 
3. Products covered (provide tariff item numbe r(s) as specified in national schedules 
deposited with the WTO;  ICS numbers should be provided in addition, where 
applicable):  Vitamin D 2 yeast in yeast-containing baked products 
4. Regions or countries likely to be affected, to the extent relevant or practicable: 
[X] All trading partners   
[ ] Specific regions or countries:    
5. Title of the notified document:  Lallemand, Inc., Filing of Food Additive Petition;  Notice 
Language:  English  Number of pages:  1   
6. Description of content:  FDA is announcing that Lallemand, Inc. has filed a petition 
proposing that the food additive regulations in  21 CFR part 172 be amended to allow for 
the safe use of vitamin D 2 yeast in yeast-containing baked products. 
7. Objective and rationale:  [X] food safety, [ ] animal health, [ ] plant protection, [ 
] protect humans from animal/plant pest or  disease, [ ] protect territory from other 
damage from pests.    
8. Is there a relevant international stan dard?  If so, identify the standard:  
[ ] Codex Alimentarius Commission (e.g.  title or serial number of Codex standard 
or related text)   
[ ] World Organization for Animal Health (OIE) (e.g. Terrestrial or Aquatic 
Animal Health Code, chapter number)    
[ ] International Plant Protection Convention (e.g. ISPM number)    
[X] None Does this proposed regulation conform to the relevant international standard?   
 [ ] Yes   [ ] No 
 If no, describe, whenever possible, how and why it deviates from the 
international standard:    G/SPS/N/USA/1966 
Page 2  
 
  9. Other relevant documents and language(s) in which these are available:  Notice of 
filing in Federal Register (74 FR 66979) can be found at: http://edocket.access.gpo.gov/2009/pdf/E9-29961.pdf
 (available in English) 
10. Proposed date of adoption (dd/mm/yy) :  To be determined 
Proposed date of publication (dd/mm/yy) :  To be determined 
11. Proposed date of entry into force:  [ ] Six months from date of publication , and/or  
(dd/mm/yy) :  To be determined 
[ ] Trade facilitating measure   
12. Final date for comments:  [ ] Sixty days from the date of circulation of the notification 
and/or (dd/mm/yy) :  Comments will be accepted anytime after publication of the notice of 
filing;  however, if a final rule is promul gated, it will address only those comments that 
were received prior to publication of the final rule. 
Agency or authority designated to handl e comments:  [ ] National Notification 
Authority, [ ] National Enquiry Point.  Address, fax number and e-mail address (if 
available) of other body:  Submit written comments on the document to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852, United States.   Submit comments by indicating DOCKET 
Number FDA-2009-F-0570 and Title of docum ent:  Lallemand Inc., Filing of Food 
Additive Petition;  Notice. 
13. Texts available from:  [X] National Notification Authority, [ ] National Enquiry Point.  
Address, fax number and e-mail address (if available) of other body:   United States 
SPS National Notification Authority, USDA Fore ign Agricultural Service, International 
Regulations and Standards Division (IRSD), Stop 1027, Washington D.C. 20250;  Tel:  
+(1 202) 720 1301;  Fax:  +(1 202) 720 0433;  E-mail:  us.spsenquirypoint@fas.usda.gov  
Notice can be found at http://edocket.access.gpo.gov/ 2009/pdf/E9-29961.pdf